HD11 for Intermediate Stages

University of Cologne

Status and phase: Completed; Phase 3

Conditions: Hodgkin´s Lymphoma

Treatments: Drug: Bleomycin; Drug: Prednisone; Drug: DTIC; Radiation: radiation therapy; Drug: Etoposide; Drug: Vinblastine; Drug: Procarbazine; Drug: Vincristine; Drug: Adriamycin

Study type: Interventional

Funder types: Other

Identifiers

NCT00264953

HD11

Details and patient eligibility

About

This study is designed to (1) compare the efficacy of the BEACOPP regimen with that of ABVD as a 4-cycle chemotherapy combined with an involved field irradiation and (2) to define the optimum radiation dose comparing of 30 to 20 Gy in the same context.

Enrollment: 1,395 patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hodgkin´s lymphoma (histologically proven)

• CS (PS) IA, IB, IIA, with one of the risk factors a-d CS (PS) IIB only with risk factor c or d

  1. bulky mediastinal mass (> 1/3 maximum transverse thorax diameter)
  2. extranodal involvement
  3. ESR > 50 (A), > 30 (B-symptoms)
  4. 3 or more lymph node areas involved

• written informaed consent

Exclusion criteria

• Leukocytes <3000/microl
• Platelets <100000/microl
• Hodgkin´s Disease as "composite lymphoma"
• Activity index (WHO) < grade 2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

1,395 participants in 4 patient groups

A

Active Comparator group

Description:

4x ABVD plus 30Gy IF-RT

Treatment:

Drug: Bleomycin

Drug: DTIC

Drug: Adriamycin

Radiation: radiation therapy

Drug: Vinblastine

C

Experimental group

Description:

4x BEACOPP baseline plus 30Gy IF-RT

Treatment:

Drug: Procarbazine

Drug: Bleomycin

Drug: Vincristine

Drug: Prednisone

Drug: Adriamycin

Radiation: radiation therapy

Drug: Etoposide

B

Experimental group

Description:

4x ABVD plus 20Gy IF-RT

Treatment:

Drug: Bleomycin

Drug: DTIC

Drug: Adriamycin

Radiation: radiation therapy

Drug: Vinblastine

D

Experimental group

Description:

4x BEACOPP baseline plus 20Gy IF-RT

Treatment:

Drug: Procarbazine

Drug: Bleomycin

Drug: Vincristine

Drug: Prednisone

Drug: Adriamycin

Radiation: radiation therapy

Drug: Etoposide